Clinical trial · Interventional
The Value of CE-LUS During Robot-assisted Surgery for Primary Colorectal Cancer
The Value of Contrast Enhanced Laparoscopic Ultrasound Examination During Robot-assisted Surgery for Primary Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Laparoscopic ultrasound examination performed during surgery for primary cancer of the colon and rectum (CRC) has been shown to be able to detect liver metastasis that are not recognized by conventional computer tomography (CT scan) prior to surgery. Today most of the colorectal cancer resections are performed by laparoscopy, but robotic technology is gradually developed in an attempt to overcome some of the limitations characterized by laparoscopy. The use of contrast enhanced laparoscopic ultrasound examination (CE-LUS) of the liver during robot-assisted CRC surgery has not been studied, and this despite the fact that it seems technically possible to perform. With this project we will investigate whether CE-LUS associated with robotic surgery for CRC is technically feasible and whether it will be able to detect synchronous liver metastases that have not been detected on the preoperative imaging modalities.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CE-LUS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CE-LUS
- description
- Laparoscopic ultrasound examination (LUS) of the liver during robot assisted CRC surgery. The liver is systematically scanned for unrecognized liver metastases. After the laparoscopic LUS procedure, the liver is then systematically scanned with contrast enhancement with SonoVue® containing Sulphurhexafluoride. A bolus of 2.5 ml is injected into a peripheral vein followed by 10 ml of isotonic saline. The liver is then systematically scanned in 3 phases (arterial, venous and parenchymatous phase) searching for unrecognized liver metastases. The procedure is repeated after 5 minutes. The time it takes to do the scan is measured and any technical challenges are reported. Time, challenges and findings of liver metastases (number, segment and size) are entered on a registration form.
- interventionNames
- Procedure: CE-LUS
Primary outcomes (1)
- measure
- Detection of synchronous liver metastases with CE-LUS
- timeFrame
- 3 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients scheduled to robot-assisted CRC resection * patients with histologically verified cancer i colon or rectum * informed consent * patients with minimum age of 18 * patients without liver metastases Exclusion Criteria: * patients who have not given informed consent * patients with severe heart disease, lung hypertension, or had had a heart attack \< 7 days * patients with alcohol or drug abuse. * patients with liver metastases
References
Publications (0)
Data not yet available